Hobbs Medical Spray Catheter Recalled for Incorrect Expiration Date
Hobbs Medical is recalling Spray Catheter devices due to incorrectly labeled expiration dates that extend shelf life beyond the actual safe-use period. The recall affects 275 units distributed between March 2018 and September 2020.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall with a labeling error on a medical device. No illnesses or injuries have been reported. The hazard is theoretical—devices labeled with extended expiration dates could be used beyond their true safe-use period. Per the rubric, theoretical hazards without reported injury score at most 3.
Plain-English summary
Hobbs Medical, Inc. is recalling The Mistifier Spray Catheter (2.6mm, 260cm, Reference 2190), a disposable medical device used in endoscopy procedures. The affected catheters were distributed with incorrect expiration dates printed on the device labels.
The device labels display expiration dates that extend beyond the actual safe-use period of the products. This labeling error means devices could be used beyond their true expiration date, potentially affecting device integrity and safety during endoscopy procedures.
Approximately 275 units were distributed worldwide, including throughout the United States and to Canada, Austria, Belgium, Finland, and Norway. The affected devices were distributed between March 25, 2018, and September 28, 2020, and carry lot numbers ending in 'R' (H02-18-166R, H02-18-167R, H02-18-168R, H02-18-169R, H04-18-214R, H11-17-182R). Healthcare providers should immediately remove affected devices from use and verify expiration dates on any remaining stock before patient use.
The recalled product
- Product
- Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- mis-labeling
- shelf-life-extension
Distribution
Distributed nationwide across the United States.
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